I am contacting you today regarding an incident of serious non-compliance with
the NIHGPS at
Vanderbilt University, a substantial recipient of NIH grants.

As you know, the National Institutes of Health Grants Policy Statement says:

“Charges to NIH grant awards for the conduct of live vertebrate animal
activities during periods of
time that the terms and conditions of the grant award are not upheld are not
allowable. Specific
situations under which charges are not allowable are:

The conduct of animal activities in the absence of a valid Animal Welfare
Assurance on filewith OLAW.

The conduct of animal activities in the absence of a valid IACUC approval of
the activity.Absence of IACUC approval includes failure to obtain IACUC approval, expiration,
orsuspension of IACUC approval.

. . . In cases where charges have been made for unauthorized animal activities,
appropriate adjustments must be made to the grant to remove those charges.”

In a USDA inspection report for Vanderbilt University dated 6/13/11 (attached),
the facility is
cited for a violation of section:

“2.31 Institutional Animal Care and Use Committee (IACUC) (c) IACUC functions.
With respect to
activities involving animals, the IACUC, as an agent of the research facility
shall: (7) Review and
approve, require modifications in (to secure approval), or withhold approval of
proposed significant
changes regarding the care and use of animals in ongoing activities:

Protocol M/06/552 as approved includes a description of a craniotomy
procedure that involves
placement of a polymer and replacement of the bone flaps but does not mention
placement of any
permanent chambers. Medical records for NHP 4414 show that a craniotomy with
placement of a
permanent chamber was performed. Medical records show repeated medical problems
related to the
chamber culminating in removal of the chamber 3 months later. To ensure the
IACUC has knowledge
of proposed activities and can review them to ensure that they meet
requirements, the IACUC must
review and approve, require modifications in to secure approval or withhold
approval of proposed
significant changes regarding the care and use of animals in ongoing
activities.”

This inspection report further cites Vanderbilt for other relevant violations:

“Section 2.31 Institutional Animal Care and Use Committee (IACUC) (d) IACUC
review of activities
involving animals. (1) In order to approve proposed activities or proposed
significant changes in
ongoing activities, the IACUC shall conduct a review of those components of the
activities related to
the care and use of animals and determine that the proposed activities are in
accordance with this
subchapter unless acceptable justification for a departure is presented in
writing; . . . Further, the
IACUC shall determine that the proposed activities or significant changes in
ongoing activities meet
the following requirements: (viii) Personnel conducting procedures on the
species being maintained
with be appropriately qualified and trained in those procedures;

A researcher who is not listed as an approved surgeon on protocol M/06/52
performed a craniotomy
surgery on NHP 4414 in September. 2010. Immediately post-surgery the NHP
presented with
complications requiring treatment by the veterinary staff. Additional imaging
and surgical procedures
were conducted in Dec. 2010 and in April 2011 by three other persons also not
approved on the
protocol. The IACUC must be made aware of personnel conducting procedures on
species being
studied on a protocol in order to be able to assess that the persons are
qualified and trained in the
procedures that will be required for that protocol. In order to approve proposed
activities the IACUC
shall determine that the personnel conducting procedures on species being
maintained or studied will
be appropriately qualified and trained in those procedures.”

It is clear that the staff of Vanderbilt University were in violation not only
of the Animal
Welfare Act for performing unapproved and therefore illegal surgical procedures
on a primate, but also
because the unapproved procedures were in fact performed by a surgeon who was
not approved as
participating in the protocol, and the botched surgery led to additional
unapproved surgical procedures
performed by no less than three additional unapproved surgeons.

Therefore, since multiple unapproved surgical procedures were performed on NHP
4414 by
multiple unapproved surgeons, it is patently obvious that in the instance of
this animal, Vanderbilt
University was in violation of the above quoted section of the NIHGPS as listed
above, and the
NIHGPS also states that:

“In cases where charges have been made for unauthorized animal activities,
appropriate adjustments
must be made to the grant to remove those charges.”

Therefore, I must insist that the National Institutes of Health, in conjunction
with the Office of
the Inspector General, immediately launch an investigation of all use of
non-human primates at
Vanderbilt University to discern an overall quantity of unapproved surgical
procedures performed on
animals by unapproved surgeons, and that following this determination, a
refunding of relevant grant
amounts be required of Vanderbilt University.

I am sure that the National Institutes of Health and the Office of the
Inspector General are both
very concerned with insuring that grantees follow all parts of the NIHGPS and
that insuring that
serious offenders be required to return illegally used NIH funding.

I hereby request a copy of all documents regarding this investigation under
the federal Freedom
of Information Act, 5 U.S.C. sec. 552. at the completion of this process.